Aptima

Aptima - HPV Screening Controls

A material that is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OYB

Device Name: Kit, Rna Detection, Human Papillomavirus

Device Class: 3

Physical State: Device is supplied as an in vitro diagnositc kit containing various reagents, instructions for use and possibly instrumentation and software.

Definition: For the detection of human papillomavirus RNA to aid in assessing risk of cancer.

Submission Type ID: 2

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Utilizes nucleic acid probes and/or primers along with other reagents to detect human papillomavirus RNA directly from human specimens

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Currently, this type of device is only utilized on cervical specimens, but other specimen types are possible.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 15420045500082

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A